The following data is part of a premarket notification filed by Clinical Sciences, Inc. with the FDA for Toxoplasma Igg Clin-elisa Test Kit Cat. No. 4560.
Device ID | K860773 |
510k Number | K860773 |
Device Name: | TOXOPLASMA IGG CLIN-ELISA TEST KIT CAT. NO. 4560 |
Classification | Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii |
Applicant | CLINICAL SCIENCES, INC. 30 TROY RD. Whippany, NJ 07981 |
Contact | Marylou Panico |
Correspondent | Marylou Panico CLINICAL SCIENCES, INC. 30 TROY RD. Whippany, NJ 07981 |
Product Code | LGD |
CFR Regulation Number | 866.3780 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-03-03 |
Decision Date | 1986-05-23 |